What Do California, Vermont, And Alabama Have In Common?

Introduction

Following a decidedly minority view, the Alabama Supreme Court joined California and Vermont in adopting the so-called "innovator liability doctrine."1 In so doing, the Alabama Supreme Court became the first state supreme court in the country to recognize brand-name manufacturer liability for a generic drug sold by another manufacturer, departing from "the overwhelming majority of courts" that have rejected the innovator liability theory.2

Under Alabama law, brand-name manufacturers may be held liable for fraud or misrepresentation in a case involving ingestion of a generic drug.

In a case of first impression, the Alabama Supreme Court recently answered the following certified question:

May a brand-name drug manufacturer be held liable for fraud or misrepresentations in a case involving ingestion of a generic drug?

In Wyeth, Inc. v. Weeks,3 the Alabama Supreme Court answered "yes," holding a plaintiff claiming personal injury from a generic product may maintain a misrepresentation claim against the brand manufacturer.4

Prior to certification by the Supreme Court, the Middle District of Alabama denied the brand-name manufacturer's motion to dismiss, holding that plaintiffs had properly pleaded their claim that the brand-name defendants perpetuated a fraud on plaintiffs' physician.5 The Middle District's holding created an intrastate split in Alabama, thus warranting certification by the Alabama Supreme Court regarding the liability of a brand manufacturer for warnings provided to a physician by a generic manufacturer.6

Under Alabama's learned intermediary doctrine, "[a] prescription drug manufacturer fulfills its duty to warn the ultimate users of the risks of its products by providing adequate warnings to the learned intermediaries who prescribe the drug."7 Specifically, a plaintiff-patient must show that "the prescribing physician would not have prescribed the medication to his patient."8 Plaintiffs Mr. and Mrs. Weeks brought suit against five brand and generic manufacturers of the pharmaceutical drug product Reglan alleging failure to adequately warn Mr. Weeks' prescribing physician of Reglan's risks which resulted in physical injury to Mr. Weeks.9

The court relied heavily on the United States Supreme Court's holding in PLIVA, Inc. v. Mensing 10 that "because the FDA prevented the generic-drug manufacturers from independently changing the safety label on their generic drugs, 'it was impossible for the Manufacturers to comply...